薬事・食品衛生審議会資料

 

平成10年05月19日

 

 

食品添加物の指定、使用基準の改正に関する食品衛生調査会、毒性部会及び添加物部会合同部会報告について - 別紙1 資料リスト

 

別紙1

資料リスト

Ⅰ.起源及び発見の経緯等に関する資料

料番号

1-a 食品科学大事典(講談社) p.176-177

1-b 第十二改正日本薬局方解説書 p.C-842-C-848

1-c GEORGIEFF M., MOLDAWER L. L., BISTRIAN B.R., BLACKBURN G.L. (1985)Xylitol, an Energy Source for Intravenous Nutrition after Trauma Journal of Parenteral and Enteral Nutrition. p.199-209. 1-d J. WASHワTTL, P. RIEDERER, E. BANCHER, A Qualitative and Quantitative Study of Sugar-Alcohols in Several FoodsJournal of Food Science Vol. 38 (1973) p.1262-1263 1-e Merck Index 10th edition p.1448

2 WHO Technical Report Series 696Evaluation of Certain Food Additives and Contaminants (1983) p.43-45

3 FAO/Food and Nutrition Paper 30 Rev. 1 (1985) Rome Evaluation by JECFA 1956~1984 p.140

4 Proposal for Council Directive on Sweeteners for use in foodstuffs.Official Journal of the European Communities No C 242/4-14 1990

5 Code of Federal Regulations 21 Chapter 1 food and Drugs Administration 1982Part 172 ubpart D p.23-24, p.42


Ⅱ. 物理化学的性質、規格及び試験法に関する資料

6 第十二改正日本薬局方 p.25-27, p.390-391

7 Specifications for identity and purity of certain food additives Joint FAO/WHO Expert Committee on Food Additives 31st Session Geneva, 1987 and 33rd Session Geneva, 1988, p.267-271, p.310-311.

8 FAO Food and Nutrition Paper 5 Rev. 1Guide to Specifications p.44-48.

9 Food Chemicals Codex Third edition, p.348-349.
First supplement to the third edition, p.11.
Third supplement to the third edition, p.153-154.

10 第六版・食品添加物公定書ガスクロマトグラフィー p.10-11.
ソルビトール p.348-349.

11 第六版 食品添加物公定書解説書(広川書店)6.ガスクロマトグラフィー p.B-21 - B-28.
ソルビトール p.D-686 - D-692.12-a カルター社のキシリトールの分析法

12-b カルター社のキシリトールの分析結果

13 食品添加物規格(案)による日本の公的試験機関の試験結果

14 食品中の食品添加物分析法解説書(講談社サイエンティフィク)p.910-912. (キシリトール)
p.369-377. (ソルビトール)15 Daniels H. et al (1982). Preservatives and Artificial Sweeteners.Gas Chromatographic Determination of Sorbitol, Mannitol, and Xylitol in Chewing Gum and Sorbitol in Mints. J. Assoc. Off. Anal. Chem. 65 p.588-591.
Ⅲ. 有効性及び安定性に関する資料

16 Technical Properties of Xylitol (Xyrofin)

17-a 水産学用語辞典 日本水産学会編 p.109

17-b 総合食品事典六版 桜井芳人編 p.489

18 キシリトールの食品への使用例 ザイロフィン社

19 IKEDA T., OKADA H., MOTODA R. & DOI Y. (1978). Effect of xylitol on certain metabolisms of streptococcus mutans.Nihon Univ. J. oral Sci., 4: p.84-87

20 Analytical Data of Xylitol about Stability for 2 years (Xyrofin)

21 Stability of Xylitol; at 60℃, 5 days (Xyrofin)

Ⅳ. 一日摂取量に関する資料■

22 平成6年版、食品産業統計年報(平成6年7月)財団法人食品産業センター p.79, 138.
Ⅴ.安全性に関する資料

23 WHO Technical Report Series 617.Evaluation of Certain Food Additives (1978) p.26.

24 WHO Food Additive Series No. 12Summary of Toxicological Data of Certain Food Additives (1977) p.124-147.

25-a WHO Technical Roport Series 631Evaluation of Certain Food Additives and Contaminants (1978) p.23-25.

25-b WHO Technical Roport Series 546Assessment of the Carcinogenicity and Mutagenicity of Chemicals (1974) p.11-12.

26 WHO Food Additive Series No. 13Summary of Toxicological Data of Certain Food Additives and Contaminants (1987) p.28-34.

27-a WHO Technical Roport series 696Evaluation of Certain Food Additives and Contaminants (1983) p.23-24.

27-b WHO Technical Roport Series 696Evaluation of Certain Food Additievs and Contaminants (1983) p.10-13.

28 WHO Food Additive Series No. 18Toxicological Evaluation of Certain Food Additives and Contaminants (1983) p.161-174.

30 WHO Technical Report Series 683Evaluation of Certain Food Additives and Contaminants (1982) p.27.

31 Commission of the European CommunitiesDirectorate-General for Internal Market and Industrial Affairs 111/A/2 Scientific Committee for Food
Report of the Scientific Committee for Food on Sweeteners, December 1984.

32 SALMINEN S.J. (1982). Investigations of the toxicological and biologicalproperties of xylitol. Thesis. Univ. of Surrey,U.K.

33 WANG Y.M., KING S.M., PATTERSON J.H. & VAN EYS J. (1973b). Mechanism of xylitol toxicity in the rabbit. Metabolism 22: p.885-893.

34 TRUHAUT R., COQUET B., FOUILLET X., GALLAND L., GUYOT D., ROUAUD J. L. & LONG D.W. (1977). Subacute toxicity of xylitol in rats; absence of hepatotoxicity. Toxicology 8: p.79-85.

35 SWARM R.L. & BANZIGER R. (1970). A thirteen week oral feeding study in rats with xylitol (Ro 6-7045). Unpublished report from Hazleton Laboratories, Inc., for F. Hoffmann-La Roche & Co., Ltd., Basle, Switzerland.

36 BANZIGER R. A. Thirteen Week Oral Toxicity Study of Xylitol in Monkeys. Unpublished report from Hazleton Laboratories Inc., for F. Hoffmann-La Roche & Co., Ltd., Basle, Switzerland, 1970.

38 HUMMLER H. (1974) Orientierende Vertr臠lichkeitsuntersuchungen ■er 6 Wochen mit Xylit, Sorbit und Saccharose am Hund. Unpublished report from Huntingdon Reserach Centre, submitted to the World Health Organization by Hoffmann La Roche Co., Basle. Switzerland.

39 PALMER A.K., BOTTOMLEY A.M., WIGHT D.G.D & CHERRY C.P. (1978). Effect of xylitol on reproductive functions of multiple generations in the rat.Unpublished report from Huntingdon Research Centre, Huntingdon, Cambridgeshire, England, for F. Hoffmann-La Roche & Co., Ltd., Basle Switzerland.

41 PALMER A.K. & BOTTOMLEY A.M. (1977). Effect of xylitol during a modified teratology study in rats. Unpublished report from Huntingdon Research Centre, Huntingdon, Cambridgeshire, England, for F. Hoffmann-La Roche & Co., Ltd., Basle, Switzerland.

42 HUMMLER H. (1978). Reproduction study in rabbits with oral administration of Ro 06 - 7045=xylitol, phaseⅠⅠ - teratology study. Unpublished internal report of F. Hoffmann-La Roche & Co. Ltd., Basle, Switzerland.

43 GALLANDRE F. (1978). Mutagenicity studies with xylitol using various methods (AMES test, host-mediated assay, micronucleus test and chromosome analysis with human lymphocytes). Unpublished internal report. F. Hoffmann-La Roche & Co., Ltd. Basle, Switzerland.

44 BATZINGER R.P., OU S.-Y. & BUEDING E. (1977). Saccharin and other sweeteners: mutagenic properties. Science 198: p.944-946.

45 SASAKI M., SUGIMURA K., YOSHIDA M.A. & ABE S. (1980). Cytogenetic effects of 60 chemicals on cultured human and Chinese hamster cells. La KromosomoⅠⅠ20: p.574-584.

46 河内 卓 他変異原生を主とする発癌物質スクリーニングの技術開発。

厚生省がん研究助成金による研究報告集 p.1111-1120.

47 石館 基 他生活関連化学物質に関する変異原生試験の現状とその評価。 衛生試験所報告 第98号 昭和55年 p.1-19.

48 HUNTER B., GRAHAM C., HEYWOOD R., PRENTICE D., ROE F. & NOAKES D. (1978b). Tumorigenicity and carcinogenicity study with xylitol in long-term dietary administration to mice. Unpublished report from Huntingdon Research Centre, Huntingdon, Cambridgeshire, England, for F. Hoffmann-La Roche & Co., Ltd., Basle, Switzerland.

49 PFITZER E.A. & KAMM J.J. Analysis of bladder stones in mice fed dietscontaining xylitol. Interoffice correspondence of Hoffmann-La Roche, Inc., Nutley, N.J. USA, 1979.50 BAR A. (1983). Modulating factors in xylitol-induced urolithiasis:comparison of NMRI vs F■linsodorf-Albino mice and comparison of different xylitol grades. Internal Research Report No. B-106'603 of F. Hoffmann-La Roche & Co. Ltd., Basle, Switzerland.

51 BトR A. (1983). Urolithiasis in xylitol-fed male f■linsdorf-Albino mice. Assessment of urinary risk factors and dose-response relationship. Internal Research Report No. B-106'605 of F. Hoffmann-La Roche & Co. Ltd., Basle, Switzerland.

52 BトR A. (1984). Effects of chronic xylitol and sorbitol ingestion on the adrenal medulla of male Fullinsdorf Albino rats. Internal Research Report No. B-106'633 of F. Hoffmann-La Roche & Co. Ltd., Basle (Switzerland).

63 BトR A. (1983e). Effect of high oral doses of xylitol vs sucrose on urinary risk factors of urolithiasis in man. Internal Research Report No. B-106'615 of F. Hoffmann-La Roche & Co. Ltd., Basle (Switzerland).

64 FヨRSTER H., QUADBECK R. & GOTTSTEIN U. (1981). Metabolic tolerance to high doses of oral xylitol in human volunteers not previoulsy adapted to xylitol. Int. J. Vit. Nutr. Res., suppl. 22: p.67-88.

65 MトKINEN K.K., YLIKAHRI R., MトKINEN P.-L., SヨDERLING E. & HトMトLトINEN M. (1981b). Turku Sugar Studies XXIII. Comparison of metabolic tolerance in human volunteers to high oral doses of xylitol and sucrose after long-term regular consumption of xylitol. Int. J. Vit. Nutr. Res., Suppl. 22: p.29-51.

66 BONNER R.A., LAINE D.C., HOOGWERF B.J. & GOETZ F.C. (1982). Effects of xylitol, fructose and sucrose in types I and II diabetics: a controlled, crossover diet study on a clinical research center. Diabetes 31, Suppl. 2: 80A (Abstr.).

67 LIFE SCIENCES RESEARCH OFFICE, (1986). Health aspects of sugar alcohols and lactose. Report prepared for the Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, D.C., under Contract No. FDA 223-83-2020 by the Life Sciences Research Office, Federation of American Societies for Experimental Biology, Bethesda, M.D.

70 BALL J.K., FIELD W.E.H., ROE F.J.C., PATH M.C. & WALTER M. The carcinogenic and co-carcinogenic effects of paraffin wax pellets and glass beads in the mouse bladder, Br. J. of Urol. 36:225-237(1964).

75 WANG Y.-M., CULBERT S.J., FRITSCHE H.A., CARR D.B., LANTIN E. & VAN EYS J. (1981). Oral xylitol in humans. Fed. Proc. 40: Abstr. No. 3684.

77 HUNTER B., COLLEY J., STREET A., HEYWOOD R., PRENTICE D. & MAGNUSSON G. (1978s). Xylitol tumorigenicity and toxicity study in long-term dietary administration to rats. Unpublished report from Huntingdon Research Centre, Huntingdon, Cambridgeshire, England, for F. Hoffmann-La Roche & Co., Ltd., Basle, Switzerland.

78 RUSSFIELD A.B. (1981). Two year feeding study of xylitol, sorbitol and sucrose in Charles River (UK) rats: adrenal medulla (Xyrofin).

92 HEYWOOD R., CHESTERMAN H., ALLEN T.R., STREET A.E., KENNEDY S.J., MAJEED S.K., & PRENTICE D.E. (1977). Xylitol toxicity study in the beagle dog. Unpublished report from Huntingdon Research Centre, Huntingdon, Cambridgeshire, England, for F. Hoffmann-La Roche & Co., Ltd., Basle, Switzerland.


Ⅵ.体内動態に関する資料

103  KUZUYA T., KANAZAWA Y. & KOSAKA K. (1969). Stimulation of insulin secretion by xylitol in dogs. Endocrinology 84: p.200-207.

104  WILSON R.B. & MARTIN J.M. (1970). Plasma insulin concentrations in dogs and monkeys after xylitol, glucose or tolbutamide infusion. Diabetes 19: p.17-22.

107  MONTAGUE W. & TAYLOR K.W. (1968). Pentitols and insulin release by isolated rat islets of Langerhans. Biochem. J. 109: p.333-339.

108  KHALID Q. & RAHMAN M. Studies of Xylito-induced insulin secretion in Vitro, Biomedicine & Pharmacotherapy, 1984, 38, 175-178.

110  LAMBERT A.E., JUNOD A., STAUFFACHER W., JEANRENAUD B. & RENOLD A.E. Organ culture of fetal rat pancreas. Biochimica et Biophysical Acta 184, p.-529-539(1969).

112  BERGER W., GOSCHKE H., MOPPERT J. & KUNZLI H. (1973). Insulin concentrations in portal venous and peripheral venous blood in man following administration of glucose, galactose, xylitol and tolbutamide. Horm. Metab. Res. 5: p.4-8.

116  HUTTUNEN J.K., MAKINEN K.K. & SCHEININ A. (1975). Turku sugar studies XI. Effects of sucrose, fructose, and xylitol diets on glucose, lipid and urate metabolism. Acta Odontol, Scand. 33, Suppl. 70: p.239-245.

117  MULLER-HESS R., GESER C.A., BONJOUR J.P., JEQUIER E. & FELBER J.P. (1975). Effects of oral xylitol administration on carbohydrate and lipid metabolism in normal subjects. Infusionstherapie 2: p.247-252.

121  BAR A. & LAMM P. (1986). Clinico-chemical investigations in Polynesian children participating in a W.H.O. caries prevention programme with xylitol. - Results of the final examination. Internal Research Report No. B-106'664 of F. Hoffmann-La Roche & Co. Ltd., Basle (Switzerland)

122  SCHMIDT B., FINGERHUT M. & LANG K. (1964). Uber den Stoffwechsel von radioaktiv markiertem Xylit bei der Ratte. Klin, Wschr., 42: p.1072-1077.

123 LANG K. (1964) Die ernahrungsphysiologischen Eigenschaften von Xylit, Internat. Z. Vitaminforsch., 34, p.117-122.

125  GRUTTE F.K. & RODEL H. (1975). Zur Bedeulung des Zuckeralkohols xylit als Zuckeraustauschstoff. Ernahrungsforschung 3: p.74-79.

126  LIEBAU K. (1964). Untersuchungen der Resorption des xylit beim Menschen. Inaugural-Dissertation. Munchen大学医学部 学位論文

127  ASANO T., LEVITT M.D. & GOETZ F.C. (1973) Xylitol absorption in healthy men, Diabetes, 22, p.279-281.

128  BASSLER K.H., PRELLWITZ W., UNBEHAUN V. & LANG K. (1962).Xylitstoffwechsel beim Menschen. Zur Frage der Eignung von Xylit als Zucker-ersatz beim Diabetiker. Klin. Wschr. 40: p.791-793.

129  QUADFLIEG K.H. BRAND K. (1974) Xylitol metabolism in human erythrocytes, Z. Phys. Chemie, 355, p.1239.

130  BIRNESSER H., REINAUER H. & HOLLMANN S. (1973) Comparative study of enzyme activities degrading sorbitol, ribitol, xylitol and gluconate in guinea pig tissues, Diabetologia, 9, p.30-33.

131  LANG K. (1974) Xylit in der oralen und parenteralen Ernahrung, Heft 75 der Schriftenreihe des Bundes fur Lebensmittelrecht und Lebensmittelkund 75, p.20-23.

132  BASSLER K.H. & REIMOLD W.V. (1965) Lactatbildung aus Zuckern undZuckeralkoholen in Erythrocyten, Klin, Wschr., 43, p.169-171.

133  FROESCH E.R. (1975) Umsatz und Verwertung von Glukose und Glukose-austauschstoffen bei Mensch und Tier, Nutr. Metabol., 18 (Suppl. 1), p.30-44.

134  BASSLER K.H. (1965) Biochemie und Stoffwechsel von Xylit (1965) Dtsch. Lebensm. Rdsd., 61, p.171-173.

135  LANG K. (1972). Xylit - Biochemie und Klinik, Z. Ernahrungswiss. Suppl. 13, 11-15. (Symp. CSSR)

136  HALMAGY1 M. (1971). Untersuchungen zum Xylitumsatz, Z. Ernahrungswiss. Suppl. 11: p.17-19.

137  FROESCH E.R. & JAKOB A. (1974) The metabolism of xylitol. "Sugars inNutrition". Sipple, H,L., McNutt, K.W.編, p.241-258, Academic Press.

138  JAKOB A., WILLIAMSON J.R. & ASAKURA T. (1971) Xylitol metabolism in perfused rat liver. Interactions with gluconeogenesis and ketogenesis, J. Biol. Chem., 246, No. 24, p.7623-7631.

139  KELLER U. & FROESCH E.R. (1972). Vergleichende Untersuchungen uber denStoffwechsel von Xylit, Sorbit und Fruktose beim Menschen, Schweiz. Med. Wochenschr. 102: p.1017-1022.

142  KUZUYA T., KANAZAWA Y. & KOSAKA K. (1966). Plasma insulin response tointravenously administered xylitol in dogs. Metabolism 15: p.1149-1152.


Ⅶ.その他の試験に関する資料

143  MELLINGHOFF G.H. (1961). Uber die Verwendbarkeit des Xylit als Ersatzzucker bei Diabetikern. Klin. Wschr. 39: p.447.

144  DUBACH U.C., FEINER E. & FORGO I. (1969). Orale Vertraglichkeit von Xylit bei stoffwechselgesunden Probanden. Schweiz. Med. Wochenschr. 99: p. 190-194.

145  FORSTER H. (1978). Tolerance in the human adults and children. In: "xylitol" J.N. Counsell編, p.43-66, Appl. Sci. Publishers Ltd., London 1978.

146  AKERBLOM H.K., KOIVUKANGAS T., PUUKKA R. & MONONEN M. (1981). The tolerance of increasing amounts of dietary xylitol in children. Int. J. Vit. Nutr. Res., Suppl. 22: p.53-66.

147  MAKINEN K.K. (1976) Long-term tolerance of healthy human subjects to high amounts of xylitol and fructose: general and biochemical findings. In: "Monosaccharides and polyalcohols in nutrition therapy and diabetics", Ed. G. Ritzel, G. Brubacher, Verlag H. Huber, 15.: p.92-104.

148  ASANO T., LEVITT M. D. & GOETZ F.C. (1972). Xylitol absorption in healthy men. Diabetes 21, Suppl. 1: p.350-351.

149  AMADOR F. & EISENSTEIN A. (1971). The effects of oral xylitol administration in human subjects. Unpublished data cited by Brin M. & Miller O.N. (1974).The safety of oral xylitol. In: "Sugars in Nutrition".Sipple, H.L. & McNutt, K.W.編, p.591-606, Academic Press, Inc., New York, 1974.

150  FORSTER H., BOECKER S. & WALTHER A. (1977). Verwendung von xylit alsZuckeraustauschstoff bei diabetischen Kindern. Fortschr. Med. 95: p.99-102.

151  HASSINGER W., SAUER G., CORDES U., KRAUSE U., BEYER J. & BASSLER K.H. (1981). The effects of equal caloric amounts of xylitol, sucross and starch on insulin requirements and blood glucose levels in insulindependent diabetics. Diabetologia 21: p.37-40.

152  MERTZ D.P., KAISER V., KLOPFER-ZAAR M. & BEISBARTH H. (1972).Serumkonzentrationen verschiedener Lipide und von Harnsaure wahrend 2 wochiger Verabreichung von Xylit. Klin. Wschr. 50: p.1107-1111.

154 CULBERT S.J.,WANG Y.M.,FRITSCHE H.A.,CARR D.,LANTIN E.& VAN EYS J.(1986).Oral xylitol in American adults.Nutr.Res.6: p.913-922.

156 YAMAGATA S.,GOTO Y.,OHNEDA A.,ANZAI M.,KAWASHIMA S.,KIKUCHI J.,CHIBA M.,MARUHAMA Y.,YAMAUCHI Y.& TOYOTA T.(1969).Clinical application of xylitol in diabetics.In:"Metabolism,physiology and clinical use of pentoses and pentitols".Horecker B.L.,Lang K.&Takagi Y.編,p.316-325,Springer Verlag,Berlin-Heidelberg-New York,1969.


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